510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Centerpoint Systems LLC

West Valley City, UT, US

CENTERPOINT SYSTEMS LLC appears in FDA device records in West Valley City, UT. FDA records list 17 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
17
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 17 510(k) clearances for Centerpoint Systems LLC between 2019 and 2026. The busiest year on record is 2026, with 5. The most recent is 2026, with 5.

Clearances by year, as a table
510(k) clearance decisions for Centerpoint Systems LLC, by decision year
YearClearances
20191
20211
20232
20244
20254
20265
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K262240SSPC NXT Delivery CatheterDQYSubstantially Equivalent
K261766CPS Locator 3D Plus Delivery CatheterDQYSubstantially Equivalent
K261492FieldFlex Steerable SheathDYBSubstantially Equivalent
K260942AuST Steerable SheathDYBSubstantially Equivalent
K260163AuST CSP IntroducerDYBSubstantially Equivalent
K250147CPS Locator 3D Delivery CatheterDQYSubstantially Equivalent
K250828CPS Locator 3D Plus Delivery CatheterDQYSubstantially Equivalent
K250492FlexiGo 3D Delivery CatheterDQYSubstantially Equivalent
K251051AuST Steerable SheathDYBSubstantially Equivalent
K243180SSPC NXT Delivery CatheterDQYSubstantially Equivalent
K242106AuST Steerable SheathDYBSubstantially Equivalent
K233752Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™ Instrument Channel CapsFBNSubstantially Equivalent
K240829AuST Steerable SheathDYBSubstantially Equivalent
K223097RenaNav Ureteroscope SystemFGBSubstantially Equivalent
K230363CPS Locator 3D Delivery CatheterDQYSubstantially Equivalent
K210009Guiding CatheterDQYSubstantially Equivalent
K190475Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery Catheter SSPC4DQYSubstantially Equivalent

Registered establishments

FDA registered establishments for Centerpoint Systems LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30159707433015970743CENTERPOINT SYSTEMS LLC3338 Parkway Blvd., West Valley City, UT 84119 US2026and 2 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain